Embargo: Immediate release Pretoria, 24 June 2022 – The South African Health Products and Regulatory Authority (SAHPRA) registered the COVID-19 vaccine, Coronavac, on 14 June 2022, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of...
17 May 2022 At a four-day meeting at the Paul-Ehrlich-Institut, representatives of the regulatory authorities in Ghana (Food and Drugs Authority, FDA), Rwanda (Food and Drugs Authority, FDA), South Africa (South African Health Products Regulatory Authority, SAHPRA) and Senegal (Agence sénégalaise de Réglementation Pharmaceutique, ARP) discussed future cooperation with vaccine...
12 May 2022Embargo: Immediate release In both the United States and South Africa, the COVID-19 Vaccine Janssen has been approved as a single primary vaccination dose, a single booster dose at least two months after the primary vaccination dose, and as a heterologous booster dose following...
As part of its ongoing response to COVID-19 communications and following a series of successful public events, the South African Health Products Regulatory Authority (SAHPRA) will be hosting a Webinar on “Vaccine Safety and Adverse Events”. The propose of the Webinar is to provide a...
11 March 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) has noted that a safety report in relation to the COVID-19 Pfizer Comirnaty vaccine directed to the United States Food and Drug Administration (FDA) has been distributed on various communication platforms in South...
17 February 2022 Embargo: Immediate release Until recently, the treatment options for patients with mild-to-moderate COVID-19 have been limited. New oral antiviral medicines are becoming available for the treatment of confirmed COVID-19 in adults who do not require supplemental oxygen and who are at risk of...
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7 February 2022 SAHPRA registered the Comirnaty vaccine from Pfizer Laboratories Pty (Ltd) on 25 January 2022, with conditions. SAHPRA also SAHPRA registered the Covid-19 Vaccine MC Pharma on 31 January 2022, with conditions. SAHPRA is currently also evaluating a number of applications for emergency use (Section...
23 December 2021 Embargo: Immediate release The South African Health Products Regulatory Authority (SAHPRA) initially registered the COVID-19 Vaccine Janssen, with conditions on 30 March 2021, in terms of section 15 of the Medicines and Related Substance Act (Act 101 of 1965). On 10 December 2021, SAHPRA received...
8 December 2021 Embargo: Immediate release The South African Health Products Authority (SAHPRA) initially approved the use of Pfizer’s Comirnaty® COVID-19 vaccine on 16 March 2021, in terms of section 21 of the Medicines and Related Substance Act (Act 101 of 1965). On 17 November 2021, SAHPRA received...
